9/03/2019

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Male breast cancer is rare, but nonetheless as deadly as for women when at the same stage of progression. Men have been traditionally excluded from breast cancer clinical trials, so any treatment for them has been developed with data from women subjects. This results in fewer FDA approved treatment options for men with breast cancer.

08/06/2019

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The Food and Drug Administration (FDA) announced the availability of the draft guidance “E8(R1) General Considerations for Clinical Studies” for public comment. The purpose of the draft guidance is to increase flexibility of clinical trials while improving the quality of clinical trial data presented to regulatory authorities. The draft guidance originates from the International Council for Harmonisation’s (ICH) E8 draft revision. The revision is part of ICH’s Good Clinical Practice (GCP) Renovation initiative, which outlines plans to revise ICH E8 and further revise ICH E6.

7/23/2019

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What does ‘T’ stand for?

Everyone talks about learning from when things go wrong. People say it's the best way to learn. But it's not always easy. The DIGR-ACT® solution gives you a way. By taking you through the issue to the root cause, actions and then making sure the actions work, you have learned from the issue. Maybe your learning can be transferred to others? Perhaps the same problem happens to other people too?